NCT01325987|CompletedDMC
African American Children, Glycemic Control, and Type 2 Diabetes
ACT
Vitamin D on Glycemic Control in African American Children With Type 2 Diabetes
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ACT
Vitamin D on Glycemic Control in African American Children With Type 2 Diabetes
Sponsor study identifier
interventional
31
1 country
1
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
June 2013
Actual (reported)Using a randomized, placebo-controlled trial design in subjects with vitamin D deficiency, the investigators propose to determine if vitamin D treatment improves glycemic control in vitamin D deficient subjects with T2DM. The investigators hypothesize that oral vitamin D treatment will improve glycemic control and ß-cell function in vitamin D deficient AA subjects with T2DM. The investigators further hypothesize that maintaining serum 25(OH)D concentrations above 20 ng/ml with oral supplementation of vitamin D will have additional glycemic control effects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 28, 2011
Actual (reported)March 30, 2011
Actual (reported)December 2012
Actual (reported)June 2013
Actual (reported)HbA1C
glycemic control
3 -4 months
AUC for c-peptide and glucose after MMTT
3- 4months
Subjects with vitamin D deficiency (serum 25(OH)D \<20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.
Subjects with vitamin D deficiency (serum 25(OH)D \<20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.
Subjects with vitamin D deficiency (serum 25(OH)D \<20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.
1. group: vitamin D2 50000 IU weekly once for 8 weeks 2. nd group: placebo weekly once for 8 weeks
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Ambika Ashraf, MD
University of Alabama at Birmingham
31 participants (actual enrollment reported by the registry).
First Submitted
March 28, 2011
First Posted
March 30, 2011
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Vitamin D3 Supplementation Pilot Study
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Primary Completion
December 2012
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
January 20, 2014
Record last verified: 2014-01
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Source: ClinicalTrials.gov.
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